MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-09-11 for 1.6MM CROSS-CUT FISSURE CARBIDE BUR 2296101316 manufactured by Stryker Instruments-kalamazoo.
[85638760]
Awaiting device evaluation. A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[85638761]
It was reported that during a tooth extraction procedure, the tip of the bur broke at the point where it connects to the shaft. It was also reported that there were no delays and no adverse consequences as a result of this event. It was further reporte that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[115089188]
Investigation results indicate that the fractured part potentially failed due to overload conditions. A review of the label, #(b)(4) , indicated that the label displays an icon which equates to "do not use excessive force" using this device.
Patient Sequence No: 1, Text Type: N, H10
[115089189]
It was reported that during a tooth extraction procedure, the tip of the bur broke at the point where it connects to the shaft. It was also reported that there were no delays and no adverse consequences as a result of this event. It was further reported that the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2017-01806 |
| MDR Report Key | 6855067 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-09-11 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-08-11 |
| Date Mfgr Received | 2017-12-07 |
| Device Manufacturer Date | 2017-04-28 |
| Date Added to Maude | 2017-09-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. UNA BARRY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.6MM CROSS-CUT FISSURE CARBIDE BUR |
| Generic Name | BUR, DENTAL |
| Product Code | EJL |
| Date Received | 2017-09-11 |
| Returned To Mfg | 2017-08-24 |
| Catalog Number | 2296101316 |
| Lot Number | 17118017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-11 |